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Bisco, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories7
Latest FDA decision2025-07-11
TypeNumberDevice NameCodeDateActions
510(k) K250156 Choice 2 DCEMA2025-07-11 View
510(k) K242816 QuantiumEBF2024-12-17 View
510(k) K192007 TheraBase, TheraBase CaEMA2020-03-17 View
510(k) K182917 FluoroCalLBH2019-11-18 View
510(k) K180344 TheraCal DCEJK2018-04-05 View
510(k) K171147 REVEAL BulkEBF2017-08-04 View
510(k) K162598 HAPI SealEBC2017-05-23 View
510(k) K163171 CeraCleanPME2017-04-14 View
510(k) K161051 All-Bond Universal w/BAC (not finalized)KLE2016-09-09 View
510(k) K161256 TheraCemEMA2016-07-29 View
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